gastro-jРоссийский журнал гастроэнтерологии, гепатологии, колопроктологииRussian Journal of Gastroenterology, Hepatology, Coloproctology1382-43762658-6673«Gastro» LLC10.22416/1382-4376-2016-6-92-100gastro-j-99Research ArticleНОВОСТИ КОЛОПРОКТОЛОГИИNEWS OF COLOPROCTOLOGYПрименение ведолизумаба при воспалительных заболеваниях кишечникаVedolizumab for inflammatory bowel diseasesIХалифИгорь ЛьвовичKhalifIgor L.ikhalif@yandex.ruШапинаМ. В.ShapinaM. V.noemail@neicon.ruФГБУ «Государственный научный центр колопроктологии им. А. Н. Рыжих»РоссияFederal government-financed institution «Ryzhikh State Scientific Center of Coloproctology»Russian Federation20161208201826692100Copyright © Халиф И.Л., Шапина М.В., 20182018Халиф И.Л., Шапина М.В.Khalif I.L., Shapina M.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.gastro-j.ru/jour/article/view/99

Цель обзора. Ознакомить с данными литературы, касающимися применения ведолизумаба при воспалительных заболеваниях кишечника. Основные положения. Ведолизумаб представляет собой гуманизированные антитела класса IgG1к α4β7-интегринам, механизм действия которых приводит к снижению миграции лейкоцитов в ткани кишечника, препятствуя тем самым развитию патологического воспаления. Исследование GEMINI-1 при язвенном колите продемонстрировало эффективность препарата в индукции ремиссии (клинический ответ у 47,1% больных, клиническая ремиссия у 16,9% и эндоскопическая ремиссия у 40,9% на 6-й неделе) и в поддержании ремиссии (клиническая ремиссия к 52-й неделе при введении препарата каждые 4 недели - 44,8%). Аналогичная эффективность показана для болезни Крона в исследовании GEMINI-2 в индукции ремиссии (клинический ответ у 31,4% пациентов, клиническая ремиссия у 14,5%) и поддержании ремиссии (клиническая ремиссия к 52-й неделе при введении препарата каждые 4 недели - 39%). Полученные в клинических испытаниях результаты подтверждены данными реальной клинической практики в разных странах. Исследования профиля безопасности выявили низкую системную иммуносупрессию за счет специфики механизма действия препарата. Кроме того, в связи с селективностью к α4β7 гетеродимеру интегрина ведолизумаб обеспечивает избирательную блокаду миграции лейкоцитов в кишечник, не влияя на центральную нервную систему, поэтому не установлен риск развития прогрессирующей мультифокальной лейкоэнцефалопатии. Заключение. В проведенных клинических исследованиях продемонстрировано, что ведолизумаб является эффективным и безопасным в лечении пациентов с воспалительными заболеваниями кишечника.

Aim of review. To present literature data on administration of vedolizumab at inflammatory bowel diseases. Summary. The vedolizumab is anti-α4β7-integrin humanized class IgG1 antibodies which suppresses migration of leukocytes in intestinal tissue, interfering thereby with development of pathologic inflammation. GEMINI-1 study of ulcerative colitis has demonstrated efficacy of the drug in remission induction (clinical response rate of 47,1% of patients, clinical remission of 16,9% and endoscopic remission of 40,9% at the 6th week) and in remission maintenance (percent of patients in clinical remission at 52nd week at drug injection every 4 weeks - 44,8%). Similar efficacy was demonstrated for Crohn's disease (GEMINI-2) study in remission induction (clinical response rate - 31,4% of patients, clinical remission - 14,5%) and remission maintenance (percentage of patient in clinical remission by 52nd week at injection of the drug every 4 weeks - 39%). The results received in clinical trials were confirmed by clinical data in the different countries. Safety profile investigations demonstrated low system immune suppression due to specific action mechanism of the drug. Besides, due to α4β7 integrin heterodimer selectivity of vedolizumab, it provides selective block of intestinal leukocyte migration, without affection of central nervous system therefore the risk of the progressing multifocal leukoencephalopathy is not established. Conclusion. Present clinical trials has demonstrated that vedolizumab is effective and safe in treatment of inflammatory bowel diseases.

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The authors declare that there are no conflicts of interest present.